CROI 2017 Abstract e-Book

Abstract eBook

Poster and Themed Discussion Abstracts

CDC, Atlanta, GA, USA Background: Antiretroviral (ARV) preexposure prophylaxis (PrEP) is highly effective in preventing HIV infection but requires laboratory monitoring. CDC recommends initial testing for renal function (serum creatinine), HIV, and hepatitis B infections; and ongoing testing for renal function, HIV, and sexually transmitted infections (STIs). To assess the uptake of these recommendations, we examined laboratory testing rates before and after PrEP initiation. Methods: Using Marketscan, a commercial insurance claims database, we followed a cohort of HIV-uninfected persons aged 18-64 years who started PrEP during 2011-2014. Their first PrEP prescription date was the index date. The sample was limited to persons continuously enrolled in the health plan for ≥ 6 months pre-index. PrEP users were followed until the earliest occurrence of a) evidence of HIV infection, b) health plan disenrollment, or c) December 31, 2014. We estimated the incidence of laboratory testing at baseline (≤ 3 months pre-index) and conducted Kaplan-Meier analyses to estimate the cumulative incidence of follow-up tests. We used Cochrane-Armitage trend test to assess if testing rates varied by index year. Results: Our cohort of 2,140 new PrEP users were followed for a median duration of 142 days (interquartile range=79-237). Prior to PrEP initiation, 53% of the cohort was tested for HIV, 32% for hepatitis B, and 28% for serum creatinine. Among the 1,261 persons who were prescribed PrEP for ≥ 3 months, at 3 months after PrEP initiation, 30% had their first monitoring testing for HIV and 20% for creatinine; at 12 months, 62% had testing for HIV and 49% for creatinine. At 6 months after PrEP initiation, 46% of the cohort had testing for syphilis and 35% for chlamydia/gonorrhea. When stratified by index year, both baseline and follow-up testing rates increased significantly from 2011 to 2014 for all tests except for creatinine. For example, the rate of baseline HIV testing was 26% in 2011 and 54% in 2014 (Ptrend < 0.001). Conclusion: For these PrEP users, laboratory testing was less frequent than recommended, although most of the testing rates improved as the number of PrEP prescriptions increased. Monitoring for HIV infection is crucial for early detection and to avoid ARV drug resistance. Other tests are important to detect possible renal toxicity of PrEP and incident STIs. There are opportunities to increase laboratory testing for PrEP users, especially for serum creatinine. Our analysis provides estimates for future evaluation.

Poster and Themed Discussion Abstracts

981 BONE CHANGES WITH TDF-CONTAINING AND NON–TDF-CONTAINING PREP IN US MEN AND WOMEN

Todd Brown 1 , Timothy Wilkin 2 , Kenneth H. Mayer 3 , Raphael J. Landovitz 4 , Ying Q. Chen 5 , Alicia Young 6 , Mark A. Marzinke 1 , Wairimu Chege 7 , Marybeth McCauley 8 , Roy M. Gulick 2 1 The Johns Hopkins Univ, Baltimore, MD, USA, 2 Weill Cornell Med, New York, NY, USA, 3 Fenway Hlth, Boston, MA, USA, 4 Univ of California Los Angeles Cntr for Clinical AIDS Rsr & Educ, Los Angeles, CA, USA, 5 Fred Hutchinson Cancer Rsr Cntr, Seattle, WA, USA, 6 Statistical Cntr for HIV/AIDS Rsr and Prevention, Seattle, WA, USA, 7 NIAID, Bethesda, MD, USA, 8 FHI 360, Washington, DC, USA Background: TDF-containing PrEP has been associated with decreases in bone mineral density (BMD) in both men and women. The BMD effects of non-TDF-containing PrEP regimens have not been reported. Methods: The HPTN 069/ACTG 5305 study randomized US men and women at risk for HIV-infection to one of 4 double-blinded, placebo-controlled regimens: maraviroc (MVC), MVC+emtricitabine (FTC), MVC+TDF, or TDF+FTC to test the safety and tolerability of these regimens. BMD was measured at the lumbar spine (LS) and hip by dual-energy x-ray absorptiometry (DXA) at baseline and 48 weeks. Adherence was assessed by detectable plasma drug concentrations (TFV and FTC: 0.31 ng/mL; MVC: 0.5 ng/mL) at 24 and 48 weeks. Percentage change in LS and hip BMD was compared between the TDF- and non-TDF (MVC±FTC) containing arms by multivariate linear regression adjusting for sex, race and baseline BMI. Results: At baseline (n=397), the median age was 32 years, 53%male, 46% black, and median Z-scores were -0.6 and -0.4 at the LS and hip respectively. Overall at the LS, the percentage change in BMD was +0.19% in the TDF arms and +0.66 % in the non-TDF arms (between group difference, -0.48% (95% CI, -1.22, 0.26)). Overall at the hip, the percentage change in BMD was -0.85% in the TDF arms and 0.09% in the non-TDF arms (between group difference, -0.94 (95% CI, -1.74, -0.13)). Among those who had detectable drugs concentrations at 24 and 48 weeks, at the LS (n=129), the percentage change in BMD was +0.89% in the TDF arms and +1.11% in the non-TDF arms (between group difference, -0.22% (95% CI, -1.36, 0.92), p=0.70). At the hip (n=131), the percentage change in BMD was -2.89% in the TDF arms and -0.95 % in the non-TDF arms (between group difference, -1.94% (95% CI, -3.23, -0.65), p=0.003). The between-group differences in percentage change in BMD did not differ by sex at either the LS or hip. Conclusion: TDF-containing PrEP was associated with greater bone loss compared to non-TDF MVC±FTC PrEP at the hip, but not the lumbar spine in both men and women. 982 PREDICTORS OF MEDICAL MALE CIRCUMCISION UPTAKE BY MEN AGED 25-39 YEARS IN NYANZA Donath Emusu 1 , Kawango Agot 2 , Jonathan Grund 3 , Paul K Musingila 4 , Frankline Onchiri 5 , Edward Mboya 2 , Jacob Onyango 2 , Eunice Omanga 2 , Elijah Odoyo-June 1 , Boaz Otieno- Nyunya 1

CROI 2017 425